Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.

Surgery--Complications Clinical Trial

— ORALEV2  

Official title:

Oral + Parenteral Antibiotic Prophylaxis Before Colonic Surgery With vs Without Mechanical Bowel Preparation: a Prospective, Multicentric, Randomised, Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161599
• Other study ID #: 2019-004283-21
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: July 2024

Study information

• Verified date: April 2022
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Eloy Espín-Basany, MD PhD
• Phone: 934 893 000
• Email: eespin[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation. The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated. No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.

Description:

International, multicentre, pragmatic, parallel-group, randomised controlled trial. Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used. Experimental group: Patients undergoing elective colonic surgery that involves colonic resection. The antibiotic prophylaxis in this group will be composed of: An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery, plus mechanical bowel preparation with Sodium picosulfate, light magnesium oxide, and anhydrous citric acid (10 mg - 3.5 g - 10.97 g per dose/ 2 doses the day before surgery) + An intravenous antibiotics pattern of cefuroxime 1,5 g and metronidazole 1 g at anesthetic induction. Control group: Patients undergoing elective colonic surgery that involves colonic resection. The antibiotic prophylaxis in this group will be composed of: An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) + An intravenous antibiotic pattern of cefuroxime 1,5 g and metronidazole 1 gr at anesthetic induction. In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time prolongs for more than three hours or if there is an intraoperative bleeding over 1000cc. There will not be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 968
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of both genders, aged 18 years or above, with colonic disease without contraindications to surgical treatment, diagnosed with neoplasia or diverticular disease (diverticulosis with indication to elective surgery: stricture, chronic constipation), patients for whom a segmental or total colectomy is indicated.
• Patients who voluntarily accept to join the study and sign a dedicated written consent.
• Capability of understanding the study and take the medications prescribed.

Exclusion Criteria:

• Patients undergoing urgent surgery or no elective admission
• Patients who refuse to participate
• Patients with rectal disease or neoplasia
• Patients with pre-existing intrabdominal sepsis (abscess, acute diverticulitis)
• Patients who received preoperative antibiotic treatment for any other reasons during the two weeks before surgery
• Patients with Crohn's disease or ulcerative colitis
• Patients unlikely to adhere to the treatment prescribed
• Patients with allergy or contraindication to the medications used in the study
• Patients who need mechanical bowel preparation
• Patients with contraindication to bowel preparation used in the study (Citrafleet®):
• Patients with kidney failure needing haemodialysis or with hypermagnesemia
• Patients with severe heart failure
• Patients with gastric or duodenal ulcer
• Patients with mechanical obstruction
• Patients with toxic megacolon
• Patients with ascites or rhabdomyolysis

Related Conditions & MeSH terms

• Surgery--Complications
• Wounds and Injuries

Intervention

Drug:
• Cefuroxime (750mg) I.V
Extra dosage

Procedure:
• Colonic Surgery
Colonic Surgery

Drug:
• Cefuroxime 750mg oral
Oral prophylaxis
• Metronidazole 250 MG Oral Tablet [Flagyl]
Oral prophylaxis
• Metronidazole 1 g Intravenous
IV prophylaxis
• Cefuroxime 1,5 g Intravenous
IV prophylaxis
• Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral
Laxative for bowel cleansing

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing
Greece	General University Hospital of Patras	Patra
Italy	Humanitas Research Hospital	Rozzano
Russian Federation	Tomsk Oncological Hospital	Tomsk
Spain	Hospital de Bellvitge	Barcelona	Hospitalet De Llobregat, Barcelona, Spain
Spain	Hospital General Universitario Vall d´Hebron	Barcelona	Barcelona, Spain
Spain	Hospital Universitario Cruces	Cruces
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Universitario Ramón y Cajal	Madrid
United Kingdom	Royal Marsden Hospital, Imperial College of London	London

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Countries where clinical trial is conducted

China,  Greece,  Italy,  Russian Federation,  Spain,  United Kingdom, 

References & Publications (1)

Pellino G, Solís-Peña A, Kraft M, Huguet BM, Espín-Basany E. Preoperative oral antibiotics with versus without mechanical bowel preparation to reduce surgical site infections following colonic resection: Protocol for an international randomized controlled — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications at 60 days of follow up	Complications and events will be recorded at 60-day follow-up, including: Primary Outcome Measure, Outcome 1: Rate of Wound infection; Secondary Outcome Measures: Outcomes 2-6 / Outcomes 9-16 / Outcome 19	60 days after surgery
Other	Complications at 5 years of follow up	Complications and events will be recorded at 5-year follow-up, including: Primary Outcome Measure, Outcome 1: Rate of Wound infection; Secondary Outcome Measures: Outcomes 2-6 / Outcomes 9-16 / Outcome 19; Readmission related with infections, with culture and antibiogram.; In patients with cancer, the following variables will also be collected: Local recurrence / Systemic recurrence	5 years after surgery
Primary	Rate of Wound infection	Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently	30 days
Secondary	Local complications	Hematoma, seroma, evisceration; This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Impaired healing	This is a Clinical measure always supported by image tests. This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Occlusive problems	Intestinal occlusion, Anastomotic stenosis, Postoperative ileus	30 days from surgery
Secondary	Nephro-urinary complications	Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...; This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Adverse events related to drugs (Harms)	Any adverse event related with the drug; •This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Time to complete recovery	Interval between hospital admission and complete recovery ("can be discharged")	30 days after surgery
Secondary	Length of Hospital stay	Hospital stay since colorectal surgery is done	Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Iatrogenic problems	Injury to structures such as ureters, bowel loops artery / veins .; •This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Bleeding problems	Hemoperitoneum, abdominal hematoma,anastomotic bleeding; •This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Cardiac complications	Acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema; This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable Cardiologist report will be required for including this items	30 days after surgery
Secondary	Respiratory complications	Pneumonia, Atelectasia, Pulmonary embolism, ARDS; This is a Clinical measure always supported by image . This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Neurological complications	Disorientation, cerebral vascular accident,; This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable. Neurologist report will be required beyond disorientation.	30 days after surgery
Secondary	Postoperative intestinal problems	Postoperative diarrhoea, nausea and vomiting	30 days after surgery
Secondary	Readmission	Need to be readmitted after discharge	30 days after surgery
Secondary	Reintervention	Need to be reoperated	30 days after surgery
Secondary	Perioperative Hypovolemia	Signs or symptoms of hypovolemia not related with bleeding, as assessed by the anesthetist at surgery	Intraoperative assessment
Secondary	Patient satisfaction with preparation received	Patient satisfaction with the preparation receivced, assessed with a Verbal Rating Scale (VRS) from 1 (minimum satisfaction) to 10 (maximum satisfaction)	within the 30 days from surgery
Secondary	Death	Patient death for any cause and patient death in relation with treatment received	30 days after surgery
Secondary	Anastomotic leak	clinical, radiological or intraoperatively detected abdominal or pelvic leak or collection	30 days after surgery